Quick answers
- What is Pilocarpine hydrochloride used for?
- The FDA-approved label (Salagen, Advanz Pharma (US) Corp., December 5, 2024) says: “SALAGEN ® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pilocarpine hydrochloride have a boxed warning?
- No. None of the 16 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Pilocarpine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pilocarpine hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started March 22, 2017 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Pilocarpine hydrochloride?
- 12 companies list prescription products of Pilocarpine hydrochloride in the FDA NDC Directory, including Amneal Pharmaceuticals NY LLC, Bryant Ranch Prepack and Sandoz Inc.
What Pilocarpine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SALAGEN ® Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
— FDA label: Salagen, Advanz Pharma (US) Corp., effective December 5, 2024. Read the full label on DailyMed →
The FDA has 16 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 16 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| pilocarpine hydrochloride 10 mg/mL solution/ drops | Generic | $3.38 per mL |
| pilocarpine hydrochloride 12.5 mg/mL solution/ drops | Generic | $19.49–$24.05 per mL 2 packages, lowest to highest |
| pilocarpine hydrochloride 20 mg/mL solution/ drops | Generic | $2.74 per mL |
| pilocarpine hydrochloride 40 mg/mL solution/ drops | Generic | $3.30 per mL |
| pilocarpine hydrochloride 5 mg tablet, film coated | Generic | $0.3105 per tablet |
| pilocarpine hydrochloride 7.5 mg tablet, film coated | Generic | $0.3408 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amneal Pharmaceuticals NY LLC6 products
- Bryant Ranch Prepack3 products
- Sandoz Inc3 products
- Somerset Therapeutics, LLC3 products
- Aurobindo Pharma Limited2 products
- Lannett Company, Inc.2 products
- Advanz Pharma (US) Corp.2 products
- Actavis Pharma, Inc.2 products
- Orasis Pharmaceuticals, Inc.1 product
- AvPAK1 product
- American Health Packaging1 product
- Amici Pharmaceuticals LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020237 SALAGEN | Advanz Pharma | March 22, 1994 | 14, latest September 10, 2015 2015: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2003: Manufacturing (CMC) |
| NDA200890 ISOPTO CARPINE | Sandoz | June 22, 2010 | 4, latest February 12, 2014 2014: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
| NDA217836 QLOSI | Orasis Pharms | October 17, 2023 | — |
Generic approvals (7)
- ANDA076963Innogenix · December 22, 2004
- ANDA077220Lannett Co Inc · October 14, 2005
- ANDA077248Impax Labs · March 31, 2006
- ANDA212377Quagen · August 13, 2019
- ANDA210384Somerset Theraps LLC · November 25, 2019
- ANDA214193Amneal · September 21, 2020
- ANDA217733Amneal · April 28, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
March 22, 2017 · Class III · Terminated · D-0679-2017
Failed Impurities/Degradation Specifications.
Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15 — Novartis Pharmaceuticals Corp.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Salagen, Advanz Pharma (US) Corp., effective December 5, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →